Compound prosthesis

ABSTRACT

A COMPOUND PROSTHESIS FOR SURGICAL IMPLANTATION IS PROVIDED WITH INTERNAL PARTITIONS THAT DIVIDE THE HOLLOW CONTAINER INTO A PLURALITY OF INTERNAL COMPARTMENTS. EACH OF THE COMPARTMENTS IS SUBSTANTIALLY FILLED WITH A SOFT FLUID GEL WHICH ALLOWS THE PROSTHESIS TO CHANGE SHAPE READILY, BUT THE COMPARTMENTALIZATION MINIMIZES ANY VISIBLE CHANGE IN SHAPE DUE TO MOVEMENTS OF THE WEARER.

Feb. 2, 1971 w. .1; PANGMAN 3,559,214

COMPOUND PROSTHE SIS Filed Oct. 17, 1968 N VliN'l UR. 14 11. 1 A44 1 Jin/6414A United States Patent 3,559,214 COMPOUND PROSTHESIS William J.Pangman, 865 Comstock Ave. W., Apt. 12A, Los Angeles, Calif. 90024 FiledOct. 17, 1968, Ser. No. 768,315 Int. Cl. A41c 3/00; A61f 1/00 US. Cl.3-36 9 Claims ABSTRACT OF THE DISCLOSURE A compound prosthesis forsurgical implantation is provided with internal partitions that dividethe hollow container into a plurality of internal compartments. Each ofthe compartments is substantially filled with a soft fluid gel whichallows the prosthesis to change shape readily, but thecompartmentalization minimizes any visible change in shape due tomovements of the wearer.

BACKGROUND OF THE INVENTION The present invention relates generally toprostheses and more particularly to an improved compound pros thesiswhich can be implanted within the human body particularly deep to thefemale breast.

It has become a practice in the field of plastic surgery to place aprosthetic implant in the area of a female 'breast under any one ofvarious conditions. In cases where cancerous, precancerous, or otherabnormal or damaged tissue has been removed, it is possible to insertthe prosthesis through the same surgical incision used for removing thetissue. The prosthesis is then a replacement for the removed tissue, andits purpose is to retain the original body contours. An implant of thischaracter provides physical support for surrounding body tissue andorgans and by filling any voids that are created by the removal of bodytissue preserves the normal outward appearance of the body.

With implants of this character, various problems are involved. One ofthem is the need of preserving the natural softness and resiliency ofthe replaced body tissue. Another problem is to retain the implant inposition in the body. One type of prosthesis used for this purposeconsists of a hollow container made of a rubberlike synthetic plasticmaterial which is molded to the desired size and shape. It is thenfilled with a liquid plastic material which can be cured; and aftercuring, becomes a fluid gel. As an example of such material, a siliconerubber is used.

This combination of materials provides the desired degree of softnessand resiliency for the replacement of removed tissues. However, becausethe fluid gel inside the prosthesis does not have enough rigidity toretain a particular shape, it shifts when the wearer changes position,as between lying down and standing up. The membrane or wall of thecontainer is sufliciently flexible that it permits a certain change inshape under the shifting weight of the fluid gel inside the prosthesis.

A prosthesis of this character sometimes produces wrinkles in the upperportion and tends to bulge excessively in the lower portion when thewearer stands or leans forward even though it is properly shaped whenthe wearer is lying down. When implanted closely under the skin, thesewrinkles become visible from the outside and, along with the bulgetowards the bottom of the prosthesis, are undesirable from a cosmeticviewpoint.

Patented Feb. 2., 1971 ice Furthermore, the shifting of the contentsmakes the prosthesis uncomfortable to wear.

Hence, it becomes a general object of the present invention to improveupon the construction of a compound prosthesis of this character toovercome the shift in position of the contents and the consequent changein shape when a highly mobile or fluid gel is used as a filler.

It is a further object of the invention to improve the construction of acompound prosthesis of this character in a manner to cause it to retainmore nearly its original shape and size without at the same timerendering the entire prosthesis stiff or lacking in pliability.

SUMMARY OF THE INVENTION These objects of the invention have beenachieved by providing a compound prosthesis which can be implanted underthe skin of a patient and comprises a hollow closed container of a soft,flexible material; partition means dividing the interior of thecontainer into a plurality of separate compartments, the partition meansalso being flexible; and a quantity of fluid gel substantially fillingeach of the compartments. A prosthesis designed to replace a femalebreast generally has a flat rear wall and an outwardly convex frontwall, and the partition means comprises a plurality of membranesextending between these front and rear walls.

Preferably, partition means divides the interior into three compartmentsof approximately equal volume, one of the compartments fillingsubstantially the upper onethird of the interior volume of thecontainer. To do this, the partition means may typically comprise amedian branch extending upwardly from the bottom of the container to alocation near the center of the container and two upwardly divergingbranches which extend upwardly away from said central location to formthe three separate compartments which are isolated from each other andwhich are individually substantially filled with the gel. Various otherconfigurations and dispositions of the interior membranes forming thepartition means are possible within the scope and spirit of the presentinvention.

DESCRIPTION OF THE DRAWING FIG. 1 is a front and side perspective of aprosthesis embodying the present invention;

FIG. 2 is a vertical median section through the prosthesis shown in FIG.1;

FIG. 3 is a vertical transverse section on line 3-3 of FIG. 2; and

FIGS. 4 and 5 are views similar to FIG. 3 of variational embodiments ofthe present invention.

DESCRIPTION OF A PREFERRED EMBODIMENT Referring now to the drawing, aprosthesis 10 is illustrated as a hollow closed shell or containerhaving a wall 12 of a soft, flexible material which is impervious tohuman tissues and to body fluid. This wall is likewise impervious to thesoft gel 14 which fills the shell. The wall 12 of the container is madeof a material which is soft and flexible and also one that is preferablyelastic. As an example of a suitable material, a silicone rubbercompound has been used with success. A wall thickness of the generalorder of 2-4 millimeters has been found to be satisfactory.

The interior space of the hollow container is divided into a pluralityof compartments by partition means. The partition means 15 is made froma material similar to the wall 12 of container so that it has the samecharacteristics of flexibility and resiliency.

The partition means indicated generally at 15 is a thin membrane of thesame material as wall 12. The container has a generally flat rear wall12a and an outwardly convex front wall 12b joined to the rear wallaround the perimeter thereof. Partition means 15 extends between thefront and rear walls and is joined to each of them to form a pluralityof separate or isolated compartments within the container. Each of thesecompartments is filled with a quantity of fluid gel 14.

The shape of the membrane forming the container means may vary; but in apreferred arrangement, there is a vertically extending median branch 16which extends upwardly from the bottom of the container to a locationcentrally of the container. Above this, the membrane consists of twoupwardly diverging branches 17 and 18 which are so arranged and spacedthat the three compartments formed thereby are more or less equal insize and accordingly, the upper compartment occupies approximatelyone-third of the volume of the container. The membrane 15 is preferablythinner than the wall 12 and is consequently more elastic. A thicknessof the order of 1-2 millimeters is satisfactory for this purpose.

The upper walls 17 and 18 preferably slope downwardly towards the frontwall 12b, as seen in FIG. 2. This slope of the partition is preferred inorder to minimize any movement of the gel in the upper compartment; andconsequently minimize the change in shape of the prosthesis during thenormal range of movements of the wearer while the torso is erect.

For reasons that are more fully explained in my earlier patent onCompound Prosthesis, No. 3,366,975, issued Feb. 6, 1968, it is preferredthat container wall 12 be completely surrounded by a covering externallayer 20 which is a resilient, foam-type plastic having numerous poresthroughout the external layer whereby it is pervious to and can beinvaded by body cellular tissue to a limited depth. A suitable materialfor this purpose is a foamed polyether or a polyurethane which can bebonded to wall 12 so that there is substantial adherence between the twolayers 12 and 20 which together provide the complete wall of container10.

Layer 20 is characterized by small pores which permit it to becomeinvaded by body tissue, thereby causing the implant to adhere firmly tothe wall of the chest and to the covering skin and tissues. Thisadherence to body tissues is most satisfactorily achieved by completelycovering wall 12 with the outer layer 20; but it will be realized thatit is also within the scope of the present invention to apply thematerial of layer 20 to less than the entire exterior surface of wall12.

DESCRIPTION OF OTHER EMBODIMENTS FIGS. 4 and 5 illustrate variationalforms of the present invention. In FIG. 4, the shape of the partitionmeans has been altered by making the two branches 17a and 18a of thepartition means curved rather than straight, when viewed in crosssection. One result of this change in shape is to increase somewhat theproportion of the total interior volume occupied by the uppercompartment.

FIG. 5 illustrates another modification in the shape of the interiorpartition means in that the branches 17b and 18b have an angularconfiguration when viewed in cross section. Furthermore, the downwardslope of the partition from rear wall 12a forwardly has been eliminated,and the partition elements 16, 17b, and 18b are all substantially normalto the general plane of rear wall 12a.

FIGS. 4 and 5 illustrate only two of various possible modifications ofthe shape and arrangement of the branches of the interior partitionmeans. From this, it will be realized that the exact proportion of theinterior volume allocated to the partitions can be varied; and likewise,the number of compartments can be more or less than three. In any case,each of the compartments is substantially filled with a fluid gel.Because of the flexible and elastic nature of the wall 12 and thepartition means as well as the fluid nature of the contents 14 of theprosthesis, the prosthesis as a whole has a soft, pliant characteristic;but the presence of the partition means forming the plurality ofinternal compartments minimizes any overall change in shape of theprosthesis as a result of a change in position of the prosthesis withmovements of the wearer.

From the foregoing description, it will be understood that variouschanges in the detailed construction and arrangement of the elements ofthe prosthesis may occur to persons skilled in the art without departingfrom the spirit and scope of the present invention. Accordingly, it isto be understood that the foregoing description is consideredillustrative of, rather than limitative upon, the invention disclosedherein.

I claim:

1. A compound prosthesis for implanting under the skin of a surgicalpatient, comprising:

a hollow closed container having a pair of spaced walls of a soft,flexible material compatible with and impervious to human tissues andbody fluid, one said wall being a rear wall and substantially flat whilethe other wall being a front wall of outwardly convex configurationjoined to the rear wall;

partition means dividing the container into a plurality of separatecompartments, the partition means being flexible membranes extendingbetween and connected to the front and rear walls; said membranes beingin a generally Y-configuration;

and a quantity of soft fluid gel substantially filling each of thecompartments.

2. A compound prosthesis as in claim 1 in which the partition meanscomprises a membrane forming one compartment of substantially the upperone-third of the interior volume of the container.

3. A compound prosthesis as in claim 1 in which the partition meansdivides the interior into three compartments of substantially equalvolume.

4. A compound prosthesis as in claim 1 in which the partition meanscomprises a median branch extending upwardly from the bottom of thecontainer to a location central of the container and two upwardlydiverging branches extending upwardly from said central location to formthree separate compartments of which one is substantially above saidcentral location.

5. A compound prosthesis as in claim 3 in which one compartment ofsubstantially one-third the interior volume of the container is disposedsubstantially above the center of the container.

6. A compound prosthesis as in claim 1 in which the partition meanscomprises membranes that are thinner and more easily deformed than theexterior wall of the container.

7. A compound prosthesis as in claim 1 in which the outer wall of thecontainer is a silicone rubber about 2-4 millimeters thick and thepartition means are membranes of a silicone rubber about 1-2 millimetersthick.

8. A compound prosthesis as in claim 1 in which the container has agenerally flat rear wall and an outwardly convex front wall,

and the partition means extending between said two walls comprises amedian branch extending down from a location central of the containerand diverging branches extending upwardly away from the central locationto form three compartments within the container;

the partition means being thinner and relatively more flexible than theouter walls.

9. A compound prosthesis as in claim 1 which also includes an externallayer of a resilient, foam-type plastic having numerous pores throughoutwhereby the external layer is relatively pervious to body fluids on bodycellular structure, said layer covering and being bonded to at least aportion of the container.

References Cited UNITED STATES PATENTS Cox 336 Bernhardt 3-36 Freedman3-36 Pangman 336 CHARLES F. ROSENBAUM, Primary Examiner J. B. MITCHELL,Assistant Examiner US. Cl. X.R. 8- 62

